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New treatment option for Idiopathic Hypersomnia
Official title A Study of TAK-360 in Adults With Idiopathic Hypersomnia
ClinicalTrials.gov ID: NCT06812078
What this study is testing
What is TAK-360?
TAK-360 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for idiopathic hypersomnia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- The participant weighs greater than or equal to (≥) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square...
- The participant has a documented, current diagnosis of IH. Key
You likely can't join if
- The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) [other than IH].
- The participant has medically significant thyroid disease.
- The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ [such as basal...
- The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C...
- The participant has a clinically significant history of head injury or head trauma.
- The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
See the full eligibility criteria
- The participant weighs greater than or equal to (≥) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) [inclusive].
- The participant has a documented, current diagnosis of IH. Key
- The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) [other than IH].
- The participant has medically significant thyroid disease.
- The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ [such as basal cell carcinoma] that has been treated and is stable, or who have been...
- The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus antibody (at screening), human immunodeficiency virus (HIV)...
- The participant has a clinically significant history of head injury or head trauma.
- The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
- The participant has a history of cerebral ischemia, transient ischemic attack (less than [\<]5 years from screening), intracranial aneurysm, or arteriovenous malformation.
The study team makes the final eligibility decision.
Where it's taking place
- Redwood City, California, United States
- Santa Ana, California, United States
- Colorado Springs, Colorado, United States
- Brandon, Florida, United States
- Winter Park, Florida, United States
- St Louis, Missouri, United States
- Denver, North Carolina, United States
- Huntersville, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbia, South Carolina, United States
- San Antonio, Texas, United States
- Norfolk, Virginia, United States
- Montpellier, Hrault, France
- Nantes, Pays de Loire, France
- Paris, France
- Shatin, Hong Kong
- Pozzilli, Isernia, Italy
- Rome, Roma, Italy
- Verona, Veneto, Italy
- Bologna, Italy
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redwood City, California, United States; Santa Ana, California, United States; Colorado Springs, Colorado, United States; Brandon, Florida, United States; Winter Park, Florida, United States; St Louis, Missouri, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.